FDA Reports Hearing Loss Linked To Viagra And Other PDE5 Inhibitors

Small but somewhat important potential side effect from these drugs, obviously important enough for the FDA to review the reports and potentially request a warning label for consumers...BD

The US Food and Drug Administration (FDA) has received reports of sudden reduction or loss of hearing following the use of PDE5 inhibitors, a class of drugs that includes the erectile dysfunction (ED) medications Viagra, Levitra, and Cialis and also Revatio, used to treat pulmonary arterial hypertension (PAH). The FDA has approved manufacturers' label changes for the ED drugs that highlight this risk more prominently and advise consumers what to do if they experience sudden problems with hearing.

The revised labelling for the ED drugs includes a new Precaution and updated Adverse Reactions Sections. A similar update is expected soon for the PAH drug, Revatio. PAH is a potentially fatal condition where continuous high blood pressure in the arteries of the lungs weakens heart muscle and can lead to heart failure and death.